REMOVAL OF TEST SUBSTANCE - Washing (if done): Not stated - Time after start of exposure: After 4 hours of exposure, the coat, the patches and the test substance were removed and the resulting reactions were evaluated 1 hour later.

SCORING SYSTEM: - Method of calculation: A primary irritation score was calculated according to 16 CFR 1500.41, 1979 by means of the 1, 24, 48 and 72 hours.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions employed, Novozym 230 had a primary irritation score of 0.0 and was classified as a "non irritant" to skin.

Executive summary:

A test for primary skin irritation in rabbits was carriedout with Novozym 230 (batch PPZ1281) according to the Code of Federal Regulations 1979, title 16, § 1500.41 with a few modifications. Instead of 24 hours the rabbits were only exposed to the test substance for 4 hours and readings were made 1, 24, 48 and 72 hours after the exposure had ended.

Under the test conditions employed, Novozym 230 had a primary irritation score of 0.0 and was classified as a "non irritant" to skin.

REMOVAL OF TEST SUBSTANCE - Washing (if done): Except for the examination at 1 hour, one drop of 1% fluorescein sodium was used. The excess of fluorescein was flushed out with 0.9% sodium chloride solution. - Time after start of exposure: The exposure period was 1 second. The eyes were examined at 1, 24, 48 and 72 hours and again 7 days.

SCORING SYSTEM: Code of Federal Regulations, title 16, § 1500.42

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Score:

0

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

0.167

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Remarks:

ulceration

Basis:

mean

Time point:

24 h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Remarks:

ulceration

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

7 d

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

7 d

Score:

0

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

7 d

Score:

0

Irritation parameter:

conjunctivae score

Remarks:

ulceration

Basis:

mean

Time point:

7 d

Score:

0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

7 d

Score:

0

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions employed, Novozym 230 was regarded as negative as to potential for eye injury, and cannot be classified under the GHS criteria.

Executive summary:

An eye irritation test on 6 albino rabbits carried out with Novozym 230 (batch PPZ1281) according to the Code of Federal Regulations, title 16, § 1500.42.

0.06 g of the test substance corresponding to the volume 0.1 mL was placed in the left eye of each rabbit by gently pulling the lower lid away from the eye ball, and the test substance was carefully introduced into

the resulting cup. The lids were then gently held together for one second. The right eye, remaining untreated, served as a control.

The treatments resulted in slight conjunctival redness in two of the rabbits until 24 hours. This effect was reversible within 48 hours.

Under the test conditions employed, Novozym 230 was regarded as negative as to potential for eye injury.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification

Not classified.

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

Route: .live2

Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.

Do not show this message again

This website uses cookies to ensure you get the best experience on our websites.